UMIN-CTR Clinical Trial

Public title

Evaluation of improving effects on fasting blood glucose of the test food.

Acronym

Evaluation of improving effects on fasting blood glucose of the test food.

Scientific Title

Evaluation of improving effects on fasting blood glucose of the test food.

Scientific Title:Acronym

Evaluation of improving effects on fasting blood glucose of the test food.

Region

Japan

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study examines improving effects on fasting blood glucose of the test food for 12weeks.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Fasting blood glucose

Key secondary outcomes

Immunoreactive insulin,
Homeostasis model assessment of insulin resistance,
Incremental blood glucose area under the curve.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of 4 packages of the test food per day for 12 weeks.

Interventions/Control_2

Intake of 4 packages of the placebo food per day for 12 weeks.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

59

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1)Aged between 20 and 59 years old at consent acquisition.
(2)Subjects whose fasting blood glucose is 100-125 mg/dL or whose blood glucose is 140-199mg/dL (at 120 minutes of glucose tolerance test).
(3)Subjects who understand the study procedures and agree to participate in the study by giving informed consent prior to the study.

Key exclusion criteria

(1)Subjects using medical products.
(2)Subjects who have a habit of ingesting medicine, health-promoting foods, foods for specified health uses, health foods that may affect this study.
(3)Females who are pregnant or lactating, or who could become pregnant or lactating during test period.
(4)Subjects who have a history of heart failure,liver failure, kidney failure, or digestive system disease.
(5)Subjects who excessively take alcohol.
(6)Subjects whose eating habits and rhythm of daily life are irregular (Shifts workers, late-night workers).
(7)Subjects who have allergy for medicine and foods.
(8) Subjects who are participating in other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate in other clinical tests.
(9) Subjects who donated over 200mL blood and/or blood components within the last one month.
(10) Males who donated over 400mL blood within the last three months.
(11) Females who donated over 400mL blood within the last four months.
(12) Males who will be collected over 1200 mL of blood when the planned sampling volume in this study is added to the volume collected within the last 12 months.
(13) Females who will be collected over 800 mL of blood when the planned sampling volume in this study is added to the volume collected within the last 12 months.
(14)Subjects who are not eligible for this study for some medical reasons.

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Fujiwara Suguru

Organization

CPCC Company Limited

Division name

Clinical Research Planning Department

Zip code

Address

4F Chusin Builging, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan

TEL

03-5297-3112

Email

cpcc-contact@cpcc.co.jp

Name of contact person

1st name
Middle name
Last name	Makoto Ichinohe

Organization

CPCC Company Limited

Division name

Plan Sales Department

Zip code

Address

4F Chusin Builging, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan

TEL

03-5297-3112

Homepage URL

Email

cpcc-contact@cpcc.co.jp

Institute

CPCC Company Limited

Institute

Department

Personal name

Organization

Nisshin Seifun Group Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

04

Month

02

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2018

Year

03

Month

15

Day

Date of IRB

Anticipated trial start date

2018

Year

04

Month

02

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

03

Month

29

Day

Last modified on

2018

Year

08

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036365